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MobileODT EVAPro Instructions For Use Manual

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Summary of Contents for MobileODT EVAPro

  • Page 2 Thank you for purchasing an EVA Pro device, by MobileODT Ltd. Please read this guide carefully before using your device. The user guide can be found online at www.mobileodt.com. Eva Pro has been designed to maximize safety and minimize strain for users and patients.

  • Page 3: Table Of Contents

    Contents INDICATIONS FOR USE ....................1 USE ENVIRONMENT ....................1 USER QUALIFICATION ....................1 DESCRIPTION ......................1 HOW SUPPLIED ......................2 CONTRAINDICATIONS ....................2 RESIDUAL RISKS ......................2 WARNING AND PRECAUTIONS ..................2 SERVICE AND MAINTENANCE..................5 REQUIRED EQUIPMENT ....................6 HANDLING AND PREPARATION ...................

  • Page 4: Indications For Use

    The handheld EVA Pro Digital Colposcope (viewing the cervix) must be used by a physician or by medical personnel under the supervision of a physician. The user must have received sufficient training in clinical procedures. MobileODT does not discuss or provide explanations of clinical procedures.

  • Page 5: How Supplied

    HOW SUPPLIED The following components are included with the MobileODT EVA Pro: ● EVA Pro Digital Colposcope Device ●...
  • Page 6 Although the EVA Pro complies with EN IEC 60601-1-2:2015 (4 ed.) EN 55011 (2009) +A1 (2010) CISPR 11 EN 55011:2016 for electromagnetic phenomena (EMC) for the Professional healthcare environment, the device may emit electromagnetic radiation that may affect the performance of other electrically powered equipment, or the performance of the device may be affected by electromagnetic radiation from other electrically powered equipment in the vicinity.
  • Page 7 14. Do not use strong detergents or alcohol under any circumstances for optics cleaning. This would lead to irrevocable damage to the optically-coated lens surfaces. 15. To limit contamination, use recommended disinfectant agents between each exam. 16. Do not use corrosive materials or strong cleaning materials other than those specifically prescribed on the casings or on the optics.

  • Page 8: Service And Maintenance

    Internet is functioning correctly. Ensure that no firewall or proxy settings on the WiFi network are limiting access to the internet. 24. The MobileODT EVA Pro device contains a 12V lithium-ion battery pack. Please observe the following practices: Do not place the device on or near fires, heaters, other high temperature locations, or apply heat directly to the unit or battery pack.

  • Page 9: Required Equipment

    WARNING: Do not submerge the EVA Pro handle, battery charger, or battery in fluid of any type. It may short the electronics and cause an electrical shock to the user. REQUIRED EQUIPMENT Before using the EVA Pro, the following equipment should be accessible: ●...

  • Page 10: Capturing A Clinically Useful Image

    Connection to stand Together with your EVA System, MobileODT Provides a device stand for stabilizing the colposcope while capturing an image. There are two types of stands: a wheeled stand and a portable stand. Below are basic instructions on connecting the colposcope to both models. See the detailed assembly instructions that came with the stand itself for further explanations.

  • Page 11: Patient Preparation

    Positioning Distance: The device should be positioned at a distance of 17-40 cm / 7-15.7 inches from the patient’s cervix. Important: the colposcope should never come into physical contact with the patient. Angle: The entire face of the cervix should be captured in the image, without any obstruction by the speculum.

  • Page 12: Teleconsultation (Zoom Telehealth)

    Installing the Zoom Application ● To request the Zoom application activation, please send an email to MobileODT support team: support@mobileodt.com and provide your username and device ID number. ● To install Zoom on the device, follow customer support instructions.

  • Page 13: Directions For Use

    • Set up - for new users • Log in - for existing users • Reset your password - by pressing “Forgot password?” • Contact MobileODT • Review our terms and conditions, as well as our privacy policy. Page 10 of 46...
  • Page 14 Setting up a user If you are new to the EVA System and did not set the password on an EVA device or on the portal click on “Set up.” Enter the email associated with your EVA user account. Click on ‘Send activation code.’ xxxxxxxx@xxxx.xxx An email will be sent with a code that needs to be entered in the next screen.
  • Page 15 Logging in If you have already set up your EVA user and have chosen a password in the system press ‘Log in’. Enter the email and password for the EVA System (the same used in the EVA device to create your EVA account). Forgot Password Click “Forgot password?”...
  • Page 16 Enter the temporary password and create a new one, then enter it once again. Limitation of active logins There is a limit of 10 active connections to the EVA System (either to multiple EVA devices or to the EVA Portal from multiple locations) that can be maintained by one user.
  • Page 17 Reviewing and editing patient examination records In the patient examination record, all the information collected about the patient during current and past examinations is displayed: patient details, documentation of the exam, images, annotations, and history of present illness. If multiple examinations of the same patient have been collected, they will be shown on the top of the patient examination record.
  • Page 18 In the image gallery view, the user can delete the specific image by pressing the ‘Delete’ button in the left bottom corner. Once it’s confirmed the image is permanently deleted from the system. In order to switch between images, the user can either press on the thumbnails below the large image to jump directly to that particular image or use the arrows on both sides of the screen to navigate through the images.
  • Page 19 Help The help button allows you to send a support request to the MobileODT support team. Enter all the details requested on the support form that opens. Export & Download Export to PDF In the exam page the options to export or download a PDF is available.
  • Page 20 Option 2- Download exam: Upon choosing this option, the user will be able to choose to download only the exam’s report as PDF, or the PDF along with the exam’s media files. Add logo to PDF Clinical admins can add a personalized logo to exported pdf exam report.
  • Page 21 The bulk download feature will send a request to MobileODT’s servers to export all of your data in encrypted files. Processing the request may take between several minutes to hours. Once the Processing is complete, an email will be sent to your account with a link that includes all the data you have as an encrypted ZIP file.
  • Page 22 Setting Up a New User Enter the EVA app by clicking the start button. On the Welcome screen, tap on ‘set up’. Enter the email address that was used to create your EVA account. Tap on ‘Next‘. An email is sent to that address with an activation code that needs to be entered in the next screen.
  • Page 23 Set a password - the password requires a minimum of eight characters including a capital letter, a lowercase letter and one number. Tap on ‘Next’. This password will allow you to access the EVA System including the EVA portal. Create a 6-digit secure PIN. The PIN will give you secure access to this particular EVA device.
  • Page 24 Having logged out from all active sessions, they can then log back in as normal. Reset PIN If the user that is presented is yours, enter the PIN to access the device. You will have 5 attempts to enter the PIN correctly. If you do not remember the PIN, tap on ‘Forgot PIN?’...
  • Page 25 A user or organization may choose to operate in ‘Opt-out’ status, meaning that none of their exam data will be uploaded or synced to the EVA Portal online storage. Opt-out status is managed by MobileODT administration. Users can request that opt-out status be applied or removed...
  • Page 26 Users are alerted that they have unread notifications when they open the EVA device, by a red dot appearing on the Main menu icon on the top left. When they enter the Main menu, an alert appears next to the Notification listing. To read notifications, tap on the Notification listing in the main menu.
  • Page 27 If no medical record number was entered, first name, last name, and date of birth (or age) will be mandatory. MRN can be entered manually or by scanning the barcode by pressing ‘Scan patient label’. Please note that at this stage you need to hold the barcode in-front of the lens.
  • Page 28 A summary of all entered information will be displayed with an option to edit every field. Capture images and videos Tap on 'Start exam' and the visualization screen will be displayed. Follow these steps to ensure you are capturing clinically-useful focused images: ●...
  • Page 29 You can also capture images without touching the device screen. To do that: move the hand in a hi-five motion towards the top of the screen. You don’t need to touch the device when doing so. When you finish capturing images to your satisfaction, tap on the green arrow button at the top right of the screen and you will be redirected to the image gallery.
  • Page 30 Add annotations To annotate an image, tap the location on the image you would like to annotate, and follow the suggested options to record the relevant details. To edit an annotation, tap on the annotation and tap on edit, following the suggested options to edit the relevant details.
  • Page 31 Summary All the information entered is displayed on the summary page. You can edit patient's details by pressing the edit button at the top of the screen. To finalize the documentation, tap on 'Finish exam' when done. The exam will start uploading to the EVA Portal. The exam will be available for further editing on the device for the next 24 hours.
  • Page 32 After setting the pin, the user will need to choose whether to export to the user’s email or to export to a folder. • Upon choosing ‘Export to my email’, the system will start exporting the examination report as a PDF. When the upload Process to the portal is completed, the exam will be sent to the user’s email.
  • Page 33 The ‘Instructions for export’ explain what should be done in order to export the exams from the device using a USB cable. In order to clear this list, which will clear up space in the external folder of the device, the user should click the ‘Clear list’...
  • Page 34 The Exams list shows exams created in chronological order with the most recent at the top. An icon next to each exam indicates the sync status (upload to the EVA online portal) One of four options might be shown; draft (if the exam has not yet been completed,) In progress (if the exam is in the process of being synced,) uploaded (if sync is completed), or Opt-out (if exam was taken while being opt-out).
  • Page 35 24 hours. Afterward, the exams viewed portal: https://eva.mobileodt.com. If the device is not connected to Wi-Fi, an option to connect to Wi-Fi is presented. The upload process only works if the device is connected to the internet.
  • Page 36 This feature is configurable from the camera setting menu. Support To reach out to MobileODT support, tap on the menu icon at the top left of the screen. In the menu section tap on 'Support'.

  • Page 37: Shutting Down

    To access the further training resources, tap on the menu icon the top left of the screen. In the menu section tap on 'Learn'. The learn button opens up MobileODT’s knowledge center which contains more articles and videos. Log out To log out tap on the menu icon the top left of the home screen.

  • Page 38: External Screen Mirroring

    ● External screen monitor with an available HDMI port (or HDMI – VGA adaptor) ● Micro HDMI to HDMI cable (not supplied by MobileODT) Step 1: Connect the Micro HDMI Cable Insert the micro HDMI plug into the Micro HDMI port on your EVA Pro device.

  • Page 39: Casting

    CASTING Wireless screen mirroring, referred to as “casting”, is supported for the camera preview and the media gallery. At this time, Chromecast is the only supported casting device. Casting the Camera Preview Open the settings panel and tap the button labeled “CONNECT CAST DEVICE”.
  • Page 40 To stop casting of the camera preview, open the settings panel and tap the button labeled “DISCONNECT CAST DEVICE”. Casting will stop and a message will appear that says, “Cast device disconnected.” The same message will appear if connection to the cast device is lost.

  • Page 41: Cleaning And Inspection

    ● Special caution should be used not to scratch the camera lens or display. INSPECTION MobileODT recommends that the EVA Pro handle be regularly inspected every month for visible damage. The following concerns should be addressed immediately: ●...

  • Page 42: Troubleshooting

    Device with a third party component or product; (d) to damage caused by service performed by anyone who is not a representative of the MobileODT; (e) to a Device that has been modified to alter functionality or capability without the written permission of MobileODT; (f) to defects caused by normal wear and tear or otherwise due to the normal aging of the Device;...

  • Page 43: Technical Assistance

    Device, and you cannot prove in any way that you are the authorized user of the Device (e.g. by presenting proof of purchase); or (k) to any damages caused due to data loss if you do not back up such data onto MobileODT’s cloud platform ,through EVA System Portal, for any reason.

  • Page 44: Technical Specifications

    TECHNICAL SPECIFICATIONS All specifications are nominal and subject to change without notice. A specification referred to as “typical” is within ±20% of a stated value at room temperature (25°C/77°F) and utilizing a sufficiently charged battery pack. DEVICE PARAMETERS Power Parameters Power Supply: 12 VDC Rechargeable Lithium-Ion...
  • Page 45 Relative Humidity: 0% to 80% non-condensing Altitude: 2000m Transport and Storage Ambient Temperature: 10° to 40°C Relative Humidity: 0% to 80% non-condensing General Info Type B Applied Parts IP21 Rating Solid particle protection: Level 2 (>12.5mm) Liquid ingress protection: Level 1 (dripping water) Wireless Communications Wi-Fi IEEE 802.11...
  • Page 46 IEC 6100-4-2 – ±8 kV contact Complies Electrostatic discharge Not Applicable ±15 kV air Complies (ESD) 2kV Mains 100kHz IEC 61000-4-4 – Electrical 1kV Signal/Data fast transient/burst No external connections 100kHz Applicable 2kV Control 100kHz 100kHz rep Rate IEC 61000-4-5 – Surge Mains 1kV LL, 2kV LG No external connections Applicable...
  • Page 47 Pulse modulation 217Hz GSM 800/900, TETRA 800, Pulse 800-960 IDEN 820, modulation CDMA 850, 18Hz LTE Band 5 GSM 1800, 1720 CDMA 1900, Pulse 1700- GSM 1900, 1845 modulation 1990 DECT, LTE 217Hz Band 1, 3, 4, 1970 25; UMTS Bluetooth, WLAN, 802.11 Pulse...
  • Page 48 Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the EVA Pro is used exceeds the applicable RF compliance level alone, the EVA Pro should be observed to verify normal operation.

  • Page 49: Symbol Definitions

    SYMBOL DEFINITIONS Symbol Standard Description Medical Devices Regulation CE Mark 2017/745 Device Name ISO 15223-1:2016 Serial Number ISO 15223-1:2016 ISO 15223-1:2016 Manufacturer & Date of Manufacture Attention! See Instructions for Use ES 60601-1:2005+A1:2012 ES 60601-1:2005+A1:2012 Type B Applied Parts CAUTION: Federal (USA) law restricts the sale of this device by or on the order of a physician MRI Unsafe ASTM F203...
  • Page 52 EVA Pro Instruction for Use 050-0009 Rev. B August 2024...

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